Philippines: New Regulatory Requirement for all Medical Devices

ARQon
Jul 8, 2021
2 min read

Initial implementation In 2018, the Philippines FDA has released an Administrative Order 2018-0002 to provide guidelines on the requirements for medical device registration and to align the registration requirements with ASEAN requirements. The initial implementation of this new framework was demonstrated via Circular 2020-001 which grouped the medical devices into four risk classes used by AMDD.

For all Class A devices, it is required to apply for a Certificate of Medical Device Notification (CMDN).
For Class B, C & D devices that are listed in the Annex A, it is required to apply for Certificate of Medical Device Registration (CMDR). Meanwhile, devices that are not in the list were exempted from registration.

New update This year in 2021, the Philippines FDA published a Circular 2021-002 to announce new requirements for previously exempted medical devices.

All remaining medical devices Class B, C & D that are not listed in the updated Annex are now needed to register under notification route (apply for CMDN), which is currently in use for Class A devices.
The updated Annex A Circular 2020-001-A which amend the classification of certain medical devices can be found here.

Guidelines

The Centre for Device Regulation, Radiation Health and Research shall be accepting application for CMDN for Class B, C & D medical devices that are not in the Annex A Circular 2020-001-A and its subsequent amendment upon the effectivity of Circular 2021-002.
CMDN for Class B, C & D medical devices is valid for 2 years.
The company have to apply for a CMDR, 3 months prior to the CMDN expiration.
Devices not specifically listed in Annex A Circular 2020-001-A are to be classified according to the AMDD.
Required documents to apply CMDN for Class B, C & D medical devices can be found in Annex A & Annex B of AO 2018-0002.
CMDN fee shall be PhP3,000 (approximately US$60) and an additional 1% Legal Research Fee (LRF).
CMDR fee shall be in accordance with the existing fees during the time of the application.